Studying how safe and effective deriphyllin is for treating breathing problems in real-life settings across multiple hospitals

ISRCTN ISRCTN11233269
DOI https://doi.org/10.1186/ISRCTN11233269
Secondary identifying numbers PN/DERI0612/06
Submission date
14/05/2025
Registration date
26/05/2025
Last edited
22/05/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
This study is looking at how safe and effective a medicine called Deriphyllin is for people with long-term breathing problems like asthma and chronic obstructive pulmonary disease (COPD). Deriphyllin is already used by many doctors because it helps open up the airways and reduce inflammation, but there isn’t much information about how well it works in everyday medical settings. This study aims to fill that gap by collecting real-world data from patients across India.

Who can participate?
Adults aged 18 years or older who have been newly prescribed deriphyllin by their doctor as an extra treatment for asthma or COPD can take part. People who have used deriphyllin before, or who have certain health conditions like serious heart problems, seizures, severe liver disease, or stomach ulcers, cannot join. Pregnant or breastfeeding women are also not eligible.

What does the study involve?
Participants will continue their usual treatment as decided by their doctor - nothing will be changed or randomly assigned. Over a period of up to 3 months, they will have regular health checks. These include breathing tests, walking tests, blood tests, heart monitoring, and surveys about symptoms and satisfaction with treatment. Doctors will also keep track of any side effects.

What are the possible benefits and risks of participating?
Participants may benefit from close monitoring of their health during the study. Their involvement could also help improve treatment for others with similar breathing problems. The risks are minimal and mostly relate to known side effects of Deriphyllin, such as nausea, trouble sleeping, or heart-related symptoms.

Where is the study run from?
The study is being carried out at 200 clinics and hospitals across India. It is coordinated by a company called Tatvacare.

When is the study starting and how long is it expected to run for?
The study will last for 6 months in total. This includes 3 months to enroll participants and up to 3 months of follow-up for each person.

Who is funding the study?
The study is sponsored by Zydus Healthcare Limited, a pharmaceutical company based in Mumbai, India.

Who is the main contact?
The main contact for the study is Dr. Kunal Jhaveri from Zydus Healthcare Limited. He can be reached by email at kunal.jhaveri@zyduslife.com

Contact information

Dr Kunal Jhaveri
Principal Investigator

Zydus Tower CTS No- 460/6 of Village Pahadi
Off I. B. Patel Road
Goregaon (East)
Mumbai
400063
India

ORCiD logo 0009-0008-5582-9576
+91 (0)9601649741
Kunal.Jhaveri@zyduslife.com
Dr Prachi Sharma
Public, Scientific

Digicare Healthcare Solutions Private Limited
Ahmedabad
380058
India

+91 (0)8290799906
patientsafety@tatvacare.in

Study information

Study designObservational prospective multi-centre study
Primary study designObservational
Secondary study designRegistry
Study setting(s)Hospital
Study typeSafety, Efficacy
Participant information sheet No participant information sheet available
Scientific titleEvaluating the safety and effectiveness of deriphyllin in respiratory disorders: a real-world multicentric study
Study acronymDERI-RWE
Study objectivesDeriphyllin, when used in routine clinical practice, is safe and effective in improving respiratory function and symptom control among patients with asthma, COPD, and other chronic respiratory conditions.
Ethics approval(s)

Approved 22/04/2025, Central Independent Ethics Committee (Gini Aria, A 703, S No. 16/2/2A/1, Kondhwa Annex, Opposite Kjei Trinity College, Kondhwa Budruk, Pune, 411048, India; +91 9975167908; info@centraliec.com), ref: ECR/390/Indt/MH/2024

Health condition(s) or problem(s) studiedChronic respiratory condition
Intervention• Tab. Deriphyllin 300 mg SR
• Tab. Deriphyllin 450 mg SR
• Tab. Deriphyllin Retard 150 mg
• Tab. Deriphyllin Retard 300 mg

Participants enrolled in this real-world observational study will be adult patients (≥18 years) with chronic respiratory conditions such as asthma or COPD who are newly prescribed Deriphyllin by their treating physician. After providing informed consent, participants will undergo baseline assessments, including vital signs, respiratory function tests (spirometry, 6-minute walk test), symptom questionnaires (mMRC, CAT, ACT), ECG, and laboratory tests (CBC, liver enzymes, serum bilirubin, and creatinine).

Participants will be followed up over a period of 12 weeks (3 months). During this follow-up period, one or two additional visits will be conducted (Visit 1 and Visit 2, if applicable) to repeat clinical assessments and monitor for adverse events. At each follow-up visit, respiratory parameters, symptom control, ECG, laboratory tests, physician assessments, and patient satisfaction will be evaluated.
No investigational intervention is assigned by the study team; deriphyllin is prescribed as part of routine clinical care. Data collection is purely observational and non-interventional.

Total duration of observation per participant: 12 weeks
Total duration of follow-up per participant: 12 weeks from enrolment
Intervention typeDrug
Pharmaceutical study type(s)Pharmacodynamic
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Deriphyllin
Primary outcome measureAdverse events/serious adverse events (SAEs): description, severity, seriousness, outcome and causality, measured using investigator assessment and spontaneous patient reporting, continuously monitored from baseline through all study visits
Secondary outcome measures1. Spirometry parameters: FEV1 (L), FEV1/FVC ratio (%), PEFR (L/min) measured using a calibrated spirometer at baseline to follow-up visits within 3 months of baseline
2. Distance walked (meters) in a standard 6-Minute Walk Test (6MWT) conducted per ATS guidelines at baseline to follow-up visits within 3 months of baseline
3. Symptom severity for COPD measured using mMRC dyspnea score (0–4) at baseline to follow-up visits within 3 months of baseline
4. COPD Assessment Test (CAT) at baseline to follow-up visits within 3 months of baseline
5. Asthma Control Test (ACT) at baseline to follow-up visits within 3 months of baseline
6. Clinician-assessed disease status (e.g., improved/stable/worsened) measured using Global Physician Assessment, investigator’s clinical judgment recorded in CRF at Visit 1 (within 3 months), visit 2 (within 3 months, if any)
7. Subject satisfaction score (e.g., on a 5-point Likert scale) at Visit 1 (within 3 months), Visit 2 (within 3 months, if any)
8. Vital signs: oxygen saturation (%), blood pressure (mmHg), pulse rate (bpm) measured using pulse oximeter and automated blood pressure monitor at baseline to follow-up visits within 3 months of baseline
9. Laboratory parameters: CBC (Hb, WBC, platelets, etc), liver enzymes: ALT, AST, GGT (U/L), serum bilirubin (mg/dL), serum creatinine (mg/dL) measured using standard automated laboratory assays from venous blood samples at baseline to follow-up visits within 3 months of baseline
10. 12-lead ECG tracing and interpretation measured using a standard ECG machine at baseline to follow-up visits within 3 months of baseline
Overall study start date22/04/2025
Completion date31/05/2026

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants4000
Key inclusion criteria1. Patients aged >18 years of either gender
2. Patients with respiratory conditions such as asthma, COPD, and other conditions who are receiving deriphyllin treatment at the discretion of the treating physician
3. Patients for whom deriphyllin is being newly initiated as an add-on to ongoing therapy and who have not received deriphyllin treatment prior to study enrollment
Key exclusion criteria1. Patients under 18 years of age
2. Patients with known hypersensitivity to theophylline, etofylline, or any other components of deriphyllin, or those using other methylxanthines (e.g., aminophylline)
3. Patients with significant cardiovascular conditions like arrhythmia, LVH with EF < 30%, and severe heart failure
4. Patients diagnosed with active peptic ulcers due to the potential exacerbation of gastrointestinal symptoms
5. Patients having a history of epilepsy or other seizure disorders
6. Patients with severe liver dysfunction
7. Pregnant and lactating females
8. Any other conditions which are not suitable for Deriphyllin treatment at the discretion of the treating physician


Date of first enrolment15/05/2025
Date of final enrolment31/12/2025

Locations

Countries of recruitment

  • India

Study participating centres

Rehmania Nursing Home
Bhiwandi
421202
India
Dr Muddebihalkar Hospital
Thane
400601
India
G2 Clinics
Mumbai
421003
India
Bhanujyot Hospital
Mumbai
421306
India
Kapil Polyclinic
Mumbai
400013
India
Maniben Health Clinic
Mumbai
400028
India
Bhavesh Rameshchandra Shah
Mumbai
400008
India
Shivanand Manjunath Nayak
Mumbai
400004
India
Shivram Gopal Chitoor
Mumbai
400084
India
Neelam Hospital
Mumbai
400070
India
Dr. James General Clinic
Mumbai
400078
India
Sagar J Raiya
Mumbai
400080
India
Suma V Menon
Sandor
401202
India
Abhinandan Clinic
Mumbai
400067
India
DR. SAVLA DIABETIC & GENERAL CARE CLINIC
Mumbai
400067
India
Kinjal Modi
Mumbai
400092
India
Yashoda Clinic
Mumbai
400060
India
Dr Subhash Bendres Clinic
Mumbai
400058
India
Green Lung Clinic
Mumbai
400062
India
Ulhas G Shirodkar
Mumbai
400058
India
Sajwan Clinic
Rasayani
410207
India
Mhatre Clinic
Alibag
402201
India
Jaewale Hospital
Osmanabad
413501
India
Chavanda Hospital
Latur
413512
India
Vivekananda Hospital
Latur
413512
India
Vishal Ramesh More
Pune
411015
India
Shree Laxmi Hospital
Pune
411014
India
Dr. Pankaj Magar's Clinic
Pune
411038
India
Shanarayan Clinic
Pune
411035
India
Pawar Clinic
Guhaghar
415703
India
Shree Healthcare
Ratnagiri
415612
India
Cpr Hospital
Kolhapur
416004
India
Spruha Chest Clinic
Kolhapur
416004
India
Pankaj Multispeciality
Sangli
416416
India
Satyajieet V Borade
Sangli
416416
India
Rahul Rama Prabhudesai
Margao
403601
India
Shwas Respiratory Clinic
Satara
415001
India
Syed Tareque S Mhussain
Nagpur
440001
India
Christanand Hospital
Brahmapuri
441206
India
Dande Hospital
Nagpur
440010
India
Saoji Hospital
Chikhali
443201
India
Gungewad Chest Clinic
Aurangabad
431001
India
Niramaya Multispeciality Hospital
Jalna
431203
India
Apeksha Hospital
Nanded
431601
India
Gavasne Hospital
Pune
413102
India
Urney Hospital
Beed
431131
India
Kulkarni Hospital
Sangamner
422605
India
Matoshri Hospital And Critical Care
Malegaon
423202
India
Muktai Hospital
Nashik
422001
India
Sapphire Hospital
Nashik
422001
India
Lilawati Hospital
Nashik
422001
India
Parsh Chest Clinic
Jalgaon
425001
India
Hope Hospital
Akola
444001
India
Mohini Clinic & Day Care Centre
Murtizapur
444107
India
Vittal Hospital
Washim
444505
India
Gsl Medical College
Rajahmundry
533101
India
Jabbilli Hospital
Rajahmundry
533102
India
Delta Hospitals
Rajahmundry
533101
India
Sri Chaitanya Clinic
Rajahmundry
533102
India
Vel Clinic
Madurai
625001
India
Sri Ram Hospital
Rajapalyam
626117
India
Maddur Medical Centre
Maddur
571428
India
Ganesh Clinic
Gonikopa
571213
India
Navdurga Daycare Center
Sardarsahar
331403
India
Dr Sandeep Chest Clinic
Sardarsahar
331403
India
Dr Prabhat Clinic
Jodhpur
342001
India
Bairwa Chest Clinic
Barmer
344001
India
Tantia Hospital
Sriganganagar
335001
India
Abdul Qayyum Ansary
Jhalawar
326001
India
Goyal Chest & Tb Clinic
Dholpur
328001
India
Nr Meena Clinic
Gangapur City
322201
India
Saini Chest Clinic
Hindaun City
322230
India
Navneet Clinic
Udaipur
313001
India
Dr Bera Chest & Tb Clinic
Pali
341001
India
Lalit Kumar Sharma
Pali
306401
India
Anil Kumar Kumawat
Pali
306401
India
Chawla Clinic
Alwar
301001
India
Vijay Tb Clinic
Tonk
304001
India
Chawda Clinic
Indore
452001
India
CHL Hospital
Indore
452001
India
Birla Hospital
Indore
452001
India
Dr Ujjawal Sharma Clinic
Owalior
474001
India
Dubey Nursing Home
Chhindwara
480001
India
Dr Sunil Manohar Singh Prakash Medical
Rewa
486001
India
Dr Pandey Clinic
Jabalpur
482001
India
SMH Hospital
Bhopal
462025
India
Sai Hospital
Bhopal
462025
India
Rai Hospital
Sagar
470001
India
Shree Clinic
Betul
460001
India
Saarathi Lung Clinic
Vadodara
390007
India
Jagdish Clinic
Vadodara
390007
India
Dr. Ankur Rawal Hospital
Khambhat
388620
India
Nisarg Kishorkumar Oza
Vadodara
390009
India
Iris Hospital
Anand
388001
India
Madhuram Multispeciality Hospital
Surat
395009
India
Sadhna Kutir Hospital
Kim
394111
India
Haria L G Rotary Hospital
Vapi
396195
India
Rangsai Clinic
Vyara
394650
India
Bajrangdas Hospital
Bhavnagar
364001
India
Jivandeep Hospital
Mahuva
364290
India
Prajna Healthcare
Ahmedabad
382424
India
Kishwa Hospital
Modasa
383315
India
Shivam Hospital
Palanpur
385001
India
Amrut Hospital
Ahmedabad
380015
India
Shivkrupa Clinic
Radhanpur
385340
India
Shaddha Clinic
Radhanpur
385340
India
Viral Multispeaciality Hospital
Rajkot
360001
India
Mmpj Hospital
Bhuj
370001
India
Divine Life Hospital
Adipur
370205
India
H. J. Doshi Hospital
Rajkot
370001
India
Prasad Health Care
Bangalore
560028
India
Geetha Clinic
Bangalore
560036
India
Sri Ganesh Clinic
Bangalore
560078
India
Sumathi Clinic
Bangalore
560062
India
United Medical Centre
Bangalore
560102
India
Sri Sai Sanjeevini Clinic
Bangalore
560102
India
Agara Chandrasekhar Raoshyam
Bangalore
560040
India
Baby Memorial Hospital
Kerala
670007
India
Wims Hospital
Wayanad
673577
India
Thoovakunnu Clinic
Kannur
670693
India
Mission Hospital
Kannur
670105
India
St. Johns Hospital
Kottayam
686014
India
Wellness Healthcare
Ettumanoor
686631
India
Sree Aanjaneya Diabetic And Medical Center
Kaviyoor
689582
India
Life Line Hospital
Adoor
691554
India
Vimala Hospital
Kanjoor
680575
India
M.a.j. Hospital
Kochi
682024
India
St. Joseph's Hospital
Kothamangalam
686691
India
Nirmala Medical Centre
Muvattupuzha
686661
India
Mother Care Hospital
Palakkad
678583
India
Karuna Medical College
Palakkad
678103
India
St James Hospital
Thrissur
680307
India
Neethi Clinic
Thrissur
680732
India
Vani Clinic
Coimbatore
641002
641002
India
Chest Hospital
Kozhikode
673005
India
Alif Poly Clinic
Malappuram
679357
India
Map Clinic
Salem
636008
India
Ark Multispeciality Hospital
Krishnagiri
635001
India
M Sankarganesh Masilamani
Shenbakkam
632004
India
Jagannatham Clinic
Tirupati
517502
India
P.b Clinic
Tirupati
517561
India
Sri Venkataramana Cinic
Tirupati
517526
India
Nataraj Clinic
Chittoor
517001
India
Venkayya Clinic
Bangarupalem
517416
India
Susheella Clinic
Palamaneru
517408
India
Anandi Hospital
Madanapalle
517590
India
Ramesh Babu Clinic
Tirupati
517502
India
Sree Ras Clinic
Tirupati
517501
India
Desu Clinic
Madanapalle
517325
India
Rajiv Garg
Lucknow
226003
India
Kedar Nath Poddar
Kolkata
700006
India
Apollo Multispeciality Hospitals
Kolkata
700054
India
Civil Hospital Rd
Sangli
416416
India
One Care Medical Center
Coimbatore
641044
India
Sun Medical And Research Center
Thrissur
680020
India
Parivar Hospital
Gwalior
474009
India
Saluja Chest Care
Meerut
250001
India
Navya Hospital
Delhi
110043
India
Apollo Clinic
Valasaravakkam
600087
India
P.sukumaran
Kottayam
686001
India
Modi Clinic- Excellence In Chest & Ent
Pune
411009
India
Health Harmony
Mumbai
400064
India
Shilpa Medical Research Centre
Mumbai
400068
India
Vora Clinic
Mumbai
400092
India
Om Clinic
Mumbai
400062
India

Sponsor information

Zydus Healthcare Ltd
Industry

Zydus Tower CTS No- 460/6 of Village Pahadi
Off I. B. Patel Road
Goregaon (East)
Mumbai
400063
India

+91 (0)9601649741
Kunal.Jhaveri@zyduslife.com

Funders

Funder type

Industry

Zydus Healthcare Ltd

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot expected to be made available
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal
IPD sharing planThe data from this study is not expected to be made available. This decision is based on the proprietary nature of the research, as the study involves formulations and methods that are commercially sensitive and owned by the sponsor, Zydus Healthcare Limited.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol file 20/05/2025 No No

Additional files

47333_PROTOCOL.pdf

Editorial Notes

20/05/2025: Study's existence confirmed by the Central Independent Ethics Committee.

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